Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.
Working closely with the Sr. Director Clinical Operations and the Development Team Leader(s), the Associate Director, Clinical Operations directs global clinical operational activities for MTDA, guiding activities and influencing colleagues in a highly matrixed environment. The incumbent will manage activities related to executing clinical studies in support of development programs in accordance with company SOPs, FDA, & ICH guidelines and regulations.
The Associate Director, Clinical Operations will lead the operational strategy for trial execution, implementation, monitoring, analysis, data delivery and regulatory submission. He/she will lead the successful execution and timelines for clinical trials drawing on a high level of expertise with clinical and regulatory requirements, both local and international, for clinical operational processes and requirements.